Clinical Data Manager II

Tailored Management; Tucson (AZ); Ibrido; USD 55.000 - 76.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical insurance

Dental insurance

Vision insurance

Weekly pay

Short-Term Disability (STD)

Long-Term Disability (LTD)

Life Insurance

AD&D Insurance

Employee Assistance Program (EAP)

Descrizione del lavoro

Tailored Management is seeking a Clinical Data Manager II in Tucson, AZ (Hybrid) to oversee data collection, cleaning, validation, and query resolution across trials. You will develop and test clinical databases and EDC systems, and automate workflows with Python.

The role requires at least 2 years of clinical data management, hands-on Python scripting, and experience with EDC platforms like Medidata Rave, Veeva Vault CDMS, REDCap or Oracle InForm, as well as CDISC SDTM/CDASH standards.

Competenze

• Bachelor's degree in Life Sciences, Computer Science, Health Informatics, Data Science, or related field.
• Minimum 2 years of clinical data management experience in clinical trials.
• Advanced hands-on Python scripting for data automation, validation, and extraction.

Mansioni

• Oversee data collection, cleaning, validation, and quality review across trials.
• Design, develop, and test clinical databases and EDC systems (UAT).
• Manage data queries, reconciliation, and resolution with sites and CROs.
• Develop and maintain Python scripts to automate data extraction, validation, and reporting.
• Identify workflow inefficiencies and implement technical solutions to improve data accuracy and efficiency.
• Support data transformation using CDISC SDTM/CDASH standards.
• Maintain documentation and ensure compliance with GCP, ICH, FDA 21 CFR Part 11.

Conoscenze

Python scripting

Data automation

Data validation

UAT

Formazione

Bachelor's degree in Life Sciences, Computer Science, Health Informatics, Data Science, or related field

Strumenti

Medidata Rave

Veeva Vault CDMS

REDCap

Oracle InForm

Descrizione del lavoro

Clinical Data Manager II

Location: Tucson, AZ (Hybrid) Pay Rate:$40-$55/hr Benefits: Weekly pay, Medical, Dental, and Vision benefits

Position Summary

We are seeking a technically skilled and proactive Clinical Data Manager II to oversee clinical data management activities across assigned clinical trials. This role is responsible for clinical database development, data collection, cleaning, validation, and query resolution to ensure data accuracy, integrity, and regulatory compliance. The ideal candidate has at least two years of clinical data management experience, advanced hands-on Python scripting skills, and experience with Electronic Data Capture (EDC) systems. The ability to automate workflows, solve technical challenges, and collaborate with cross-functional teams is essential.

Key Responsibilities

• Oversee clinical data collection, cleaning, validation, and quality review across assigned clinical trials.
• Support the design, development, and testing of clinical databases and EDC systems, including User Acceptance Testing (UAT).
• Manage data queries, reconciliation, and resolution in collaboration with clinical sites and CRO partners.
• Develop and maintain Python scripts to automate data extraction, validation, cleaning, and reporting.
• Identify workflow inefficiencies and implement technical solutions to improve data accuracy and operational efficiency.
• Support data transformation and standardization activities using CDISC SDTM/CDASH standards.
• Maintain clinical data management documentation and ensure compliance with GCP, ICH guidelines, FDA regulations, 21 CFR Part 11, and SOPs.
• Collaborate with Clinical Operations, Biostatistics, Quality Assurance, and other study teams to meet clinical trial milestones.

Required Qualifications

• Bachelor's degree in Life Sciences, Computer Science, Health Informatics, Data Science, or a related field.
• Minimum of 2 years of clinical data management experience within clinical trials.

Technical Skills

• Advanced hands-on proficiency in Python scripting for data automation, manipulation, and validation.
• Experience with EDC platforms such as Medidata Rave, Veeva Vault CDMS, REDCap, or Oracle InForm.
• Knowledge of clinical data standards, including CDISC SDTM and CDASH.
• Experience with database development, data validation, and UAT.

Regulatory & Core Competencies

• Working knowledge of GCP, ICH guidelines, FDA regulations, and 21 CFR Part 11.
• Strong analytical, problem-solving, and troubleshooting skills.
• Excellent attention to detail and data accuracy.
• Self-motivated with the ability to work independently and take ownership of projects.
• Strong written and verbal communication and cross-functional collaboration skills.

At Tailored Management, we help people get jobs and take pride in their work, so we better take pride in ours too. Not every company has the opportunity to meaningfully and directly impact individuals in a way that makes their lives tangibly better. To better support our employees, we offer a wide variety of benefit options to support you.

• Medical Coverage – HDHP, PPO, and Surest plan options
• Minimum Essential Coverage (MEC)
• Dental Insurance
• Vision Insurance
• Short-Term Disability (STD)
• Long-Term Disability (LTD)
• Life & AD&D Insurance
• Critical Illness Insurance
• Accident Insurance
• Employee Assistance Program (EAP)